← Back to Search

Checkpoint Inhibitor

Immunotherapy for Prostate Cancer (IMPACT Trial)

Q: How many participants have been admitted into this clinical study?

Unfortunately, this medical trial is not currently seeking enrolment. The research program was first announced in December 14th of 2018 and its requirements were last updated on August 1st 2022. If you're still looking for a clinical trial to join, there are presently 4361 studies involving metastatic cancers that need volunteers as well as 764 trials for Nivolumab which require participants.

Q: How many locations within the state are currently offering this clinical trial?

This health study is currently enrolling individuals at 8 medical centres simultaneously. Specifically, those in Detroit, San Diego and <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> can access treatment locally, while other enrollees may need to travel a bit further for participation.

Q: Has any additional research been conducted on Nivolumab?

Presently, there are 764 active studies for Nivolumab with 86 of those in the Phase 3 stage. The majority of these investigations have been established near Pittsburgh, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a> yet 42751 other locations across the nation also run clinical trials related to this drug.

Q: Are there any vacancies open to prospective participants in this experiment?

At the moment, this particular clinical trial is not enrolling patients. The study was first announced on December 14th 2018 and its latest update came out August 1st 2022. If you are searching for other trials, 4361 studies involving metastatic cancers have active recruitment while 764 additional studies concerning Nivolumab need participants at present.

Q: What health conditions can Nivolumab be employed to alleviate?

Nivolumab is a popular anti-angiogenic therapy, and can be used to treat malignant neoplasms, advanced <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, and <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>.

Q: To what degree is Nivolumab hazardous to individuals?

There is some evidence indicating the safety of Nivolumab, so it received a score of 2. This implies that while there are no efficacy data points yet, there have been multiple rounds confirming its security profile.

Q: What aims is this medical experiment hoping to achieve?

This medical trial will assess the efficacy of a drug over 24 months post-treatment, with primary outcome being the proportion of patients with CDK12 loss of function metastatic CRPC that respond to treatment. Secondary objectives involve measuring radiographic progression free survival time (rPFS), Progression free survival time (PFS) and Time to Progression (TTP). Radiographic progression is defined as at least 20% increase in target lesions relative to smallest sum since start of treatment or appearance of new lesions. PSA progression requires an initial decline from baseline followed by 25% rise beyond 2ng/mL for more than 4 weeks,

Phase 2

Waitlist Available

Led By Ajjai Alva, MD

Research Sponsored by University of Michigan Rogel Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with prostate cancer must have ongoing androgen deprivation with total serum testosterone < 50 ng/dL

Subjects must have a histologic or cytologic diagnosis of metastatic adenocarcinoma of the prostate without small cell histology OR another type of metastatic carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post treatment

Awards & highlights

IMPACT Trial Summary

This trial will study whether a immunotherapy drug combo can help treat prostate cancer, specifically in patients with a loss of CDK12 function.

Who is the study for?

Adults over 18 with metastatic prostate or other cancers and CDK12 mutations can join. They must have a performance status of 0-2, measurable cancer progression, and adequate organ function. Women must not be pregnant and all participants should agree to contraception. Exclusions include recent trial participation, organ transplants, certain infections, prior immunotherapy treatments, need for high-dose steroids or having autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing the effectiveness of nivolumab alone and combined with ipilimumab in treating metastatic cancers with CDK12 loss. It starts with both drugs together followed by just nivolumab for patients with prostate cancer and similar treatment for those with other solid tumors.See study design

What are the potential side effects?

Nivolumab and ipilimumab may cause immune-related side effects like inflammation in various organs (e.g., lungs or intestines), skin rash, hormone gland problems (like thyroid issues), fatigue, infusion reactions (symptoms related to the administration of these drugs), as well as potential liver or kidney issues.

IMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on hormone therapy for prostate cancer with low testosterone levels.

Select...

My cancer is a type of prostate cancer that has spread, but it's not small cell cancer.

Select...

My cancer can be measured on scans and is not prostate cancer.

Select...

My prostate cancer has worsened in the last 6 months, shown by rising PSA levels.

Select...

My cancer has a CDK12 mutation.

Select...

I am 18 years old or older.

Select...

I can take care of myself and am up and about more than half of my waking hours.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment.

Secondary outcome measures

Duration of Therapy (DOT)

Overall Survival Time

PSA Progression Free Survival Time

+5 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Bronchitis

Blood alkaline phosphatase increased

Chills

Hypertension

Dehydration

Hyperkalaemia

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Leukopenia

Hypophosphataemia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Musculoskeletal chest pain

Malaise

Pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Hypercalcaemia

Neoplasm progression

Small intestinal haemorrhage

Femur fracture

Pericardial effusion malignant

Cancer pain

Confusional state

Pneumothorax

Circulatory collapse

Bone pain

Atrial flutter

Bronchial obstruction

Superior vena cava syndrome

Syncope

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

IMPACT Trial Design

3Treatment groups

Experimental Treatment

Group I: Solid Tumors (non-prostate)Experimental Treatment2 Interventions

Patients with all other metastatic subtypes will be enrolled in cohort B

Group II: Metastatic CRPC with MonotherapyExperimental Treatment1 Intervention

Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed.

Group III: Metastatic CRPCExperimental Treatment2 Interventions

Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2670

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor

293 Previous Clinical Trials

24,041 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,933 Previous Clinical Trials

585,564 Total Patients Enrolled

University of California, San FranciscoOTHER

2,500 Previous Clinical Trials

15,236,415 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03570619 — Phase 2

Cancer Research Study Groups: Solid Tumors (non-prostate), Metastatic CRPC with Monotherapy, Metastatic CRPC

Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03570619 — Phase 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03570619 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been admitted into this clinical study?

"Unfortunately, this medical trial is not currently seeking enrolment. The research program was first announced in December 14th of 2018 and its requirements were last updated on August 1st 2022. If you're still looking for a clinical trial to join, there are presently 4361 studies involving metastatic cancers that need volunteers as well as 764 trials for Nivolumab which require participants."

Answered by AI

How many locations within the state are currently offering this clinical trial?

"This health study is currently enrolling individuals at 8 medical centres simultaneously. Specifically, those in Detroit, San Diego and New york can access treatment locally, while other enrollees may need to travel a bit further for participation."

Answered by AI

Has any additional research been conducted on Nivolumab?

"Presently, there are 764 active studies for Nivolumab with 86 of those in the Phase 3 stage. The majority of these investigations have been established near Pittsburgh, Pennsylvania yet 42751 other locations across the nation also run clinical trials related to this drug."

Answered by AI

Are there any vacancies open to prospective participants in this experiment?

"At the moment, this particular clinical trial is not enrolling patients. The study was first announced on December 14th 2018 and its latest update came out August 1st 2022. If you are searching for other trials, 4361 studies involving metastatic cancers have active recruitment while 764 additional studies concerning Nivolumab need participants at present."

Answered by AI

What health conditions can Nivolumab be employed to alleviate?

"Nivolumab is a popular anti-angiogenic therapy, and can be used to treat malignant neoplasms, advanced melanoma, and squamous cell carcinoma."

Answered by AI

To what degree is Nivolumab hazardous to individuals?

"There is some evidence indicating the safety of Nivolumab, so it received a score of 2. This implies that while there are no efficacy data points yet, there have been multiple rounds confirming its security profile."

Answered by AI

What aims is this medical experiment hoping to achieve?

"This medical trial will assess the efficacy of a drug over 24 months post-treatment, with primary outcome being the proportion of patients with CDK12 loss of function metastatic CRPC that respond to treatment. Secondary objectives involve measuring radiographic progression free survival time (rPFS), Progression free survival time (PFS) and Time to Progression (TTP). Radiographic progression is defined as at least 20% increase in target lesions relative to smallest sum since start of treatment or appearance of new lesions. PSA progression requires an initial decline from baseline followed by 25% rise beyond 2ng/mL for more than 4 weeks,"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations

2018. "Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03570619.

All > Prostate Cancer Anaheim